Providing the vision and experience to manage global submissions
We provide reliable support for all types of regulatory procedures and all types of dossiers. We coordinate your submissions, liaise with agencies, and resolve all potential hurdles.
Many of our regulatory experts have decades of experience in these activities, making Asphalion your partner of choice. We have experience in all European countries and also in FDA, LATAM countries and increasing coverage of RoW countries.
- Assessment of regional requirements
- Support and Management of registration procedures to comply with critical timelines:
- Centralized Procedures (CP) in EMA
- Decentralised Procedures (DCP) with all European Agencies and National Phases (NP)
- FDA projects (IND, NDA, BLA, ANDA)
- Global roll-out in emerging markets
- Reliable coordination of local partners for global registration procedures (RoW)
With over 13 years of handling submissions, we have gained experience in the compilation of almost all types of submission dossiers: New Chemical Entities, Biologicals and Advanced Therapy Medicinal Products, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Veterinary Medicinal Products, Medical Devices, Cosmetics and Food Supplements.
Do you need support or more information about the services? Contact us!